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Monday, 1 August 2016
(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?
This case arose because Merck Sharp & Dohme filed an SPC application one day before patent expiry but only had the "End of Procedure Communication" but not a marketing authorisation.